In the USA, the regulator found a violation at the Moderna plant: how is it related to vaccines?
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U.S. regulators have found quality control violations at biotech company Moderna’s ( MRNA.O ) main plant.
In particular, flaws were found in the equipment used to produce the substance for the vaccine against COVID-19.
This was reported by the Reuters news agency, which obtained access to the report of the US Food and Drug Administration (FDA).
From September 11 to 21, the US Food and Drug Administration conducted an inspection at the Moderna plant in Norwood, Massachusetts.
There, in particular, the spikevax mRNA vaccine against the coronavirus and an experimental cancer mRNA vaccine are being produced jointly with Merck & Co (MRK.N).
There are five observations in the FDA report. For example, Moderna is said to have released 8 batches of a substance that was produced on equipment that failed the company’s inspection of cleaning standards.
The report did not say whether the batches were released, but said the substance was intended to be used to make a vaccine against COVID-19.
| Illustrative photo: NurPhoto/Contributor/GettyImages |
The FDA also found that the factory did not take sufficient steps to avoid using expired materials and to keep airborne contaminants out of the products.
According to the report, inspectors found more than 2,000 expired products in Moderna’s warehouse and cold storage. They were not kept in a separate or clearly defined place from other materials.
At the same time, there is no evidence that violations of some of the requirements led to harm to people vaccinated with Moderna’s vaccines or to participants in clinical trials of other mRNA vaccines that the company is developing.
“After receiving the FDA’s findings, Moderna immediately and comprehensively updated the defined procedures and is confident that the measures taken will satisfy the regulatory authorities,” – the company responded to the report.
Moderna called the inspection “routine” and said its results did not reflect any problems with product quality or safety.
The company also stressed that its vaccines against COVID-19 are safe and effective, and all released products have been tested and meet international regulatory requirements.
It is also known that The FDA has not recalled any of Moderna’s vaccines.
We will remind you that the American company Moderna recently developed a new vaccine against COVID-19 – mRNA-1283, which lasts twice as long.
Read also: Experimental vaccine prevents recurrence of skin cancer – US researchers
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